[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-mechanical-bowel-obstruction-diagnosed-clinicallyradiologically-with-prior-abdominal-surgery-for-relief\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-mechanical-bowel-obstruction-diagnosed-clinicallyradiologically-with-prior-abdominal-surgery-for-relief":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100658193","postbiotics-for-gi-recovery-after-malignant-bowel-obstruction-surgery-100658193",false,"NCT07850089","Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery","Effects of Preparations of Fermented Metabolites Derived From Lactic Acid Bacteria on Postoperative Gastrointestinal Function Recovery After Resolution of Malignant Bowel Obstruction: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Clinical Study","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Age 18-80 years.\n2. Diagnosed with malignant mechanical bowel obstruction based on clinical and imaging findings, and have undergone abdominal surgery for the purpose of relieving the obstruction.\n3. Vital signs are stable within 24 hours after surgery, and the investigator judges that the subject can continue to participate in the trial.\n4. Written informed consent has been signed by the subject or their legally authorized representative before surgery or before randomization.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be enrolled:\n\n1. Presence of unresolved mechanical obstruction after surgery, or planned re-laparotomy in the short term.\n2. Short bowel syndrome or severe intestinal fistula.\n3. Persistent hemodynamic instability requiring continuous vasopressors or mechanical ventilation after surgery, or severe hepatic\u002Frenal failure that, in the investigator's opinion, makes enteral intervention inappropriate.\n4. Allergy to any component of the postbiotic preparation.\n5. Continuous use of other probiotics, prebiotics, synbiotics, or postbiotics within 2 weeks prior to randomization and inability to discontinue them; perioperative prophylactic or therapeutic antibiotics are not exclusion criteria but must be fully documented.\n6. Pregnancy or lactation.\n7. Concurrent participation in another interventional clinical trial.\n8. Any other condition that, in the investigator's judgment, makes the subject unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Objective: To evaluate the effects of the postbiotic preparation JK-5G on gastrointestinal function recovery (GI-2 time), gastrointestinal dysfunction, nutritional status, and safety in patients after surgery for malignant bowel obstruction.\n\nDesign: A randomized, double-blind, placebo-controlled, exploratory clinical trial. Patients are randomized 1:1 within 24 hours after surgery. After meeting criteria for initiating enteral intake, they receive either JK-5G or placebo (one sachet three times daily) for 10 consecutive days, and are followed up to postoperative day 30.\n\nStudy Population: Adult patients (18-80 years old) who undergo surgery for malignant mechanical bowel obstruction and are hemodynamically stable within 24 hours after surgery.\n\nSample Size: A total of 80 patients (40 in the postbiotic group and 40 in the placebo group). A blinded review of variability will be conducted after 40 patients have completed the study.\n\nPrimary Endpoint: Time from the end of surgery to GI-2 recovery, where GI-2 recovery is defined as the later of the following two events: first passage of stool\u002Feffective stoma output, and first tolerance of the target diet. Key secondary endpoints include daily I-FEED scores, incidence of prolonged postoperative ileus, achievement of nutritional targets, and safety events.\n\nStatistics and Timeline: The primary analysis will use a stratified Cox model (intention-to-treat principle). The study is planned to be conducted from September 2026 to February 2028.",[27,28,29,30],"Age 18 to 80 Years","Malignant Mechanical Bowel Obstruction Diagnosed Clinically\u002FRadiologically, With Prior Abdominal Surgery for Relief","Hemodynamically Stable Within 24h Post-op, Per Investigator","Informed Consent Obtained Before Surgery or Randomization","NOT_YET_RECRUITING","2026-09-29",{"date":34,"type":35},"2026-09-30","ACTUAL",{"date":37,"type":21},"2026-09",{"date":39,"type":21},"2028-09",{"name":41,"class":42},"First Affiliated Hospital of Wenzhou Medical University","OTHER"]